Infuseon Therapeutics Earns FDA Clearance for Novel Central Nervous System Delivery Device
– Infuseon Therapeutics’ novel central nervous system deliver device has received FDA 510(k) clearance as a therapeutic delivery device.
Infuseon Therapeutics’ Cleveland Multiport CatheterTM
(CMC), a multiport convection-enhanced delivery catheter, was designed by neurosurgeon Michael Vogelbaum, MD, PhD, from Cleveland Clinic’s Brain Tumor and NeuroOncology Center and Department of Neurosurgery, to effectively deliver therapeutics to patients at the site of their disease. FDA clearance was granted in March 2017.
“This clearance of the CMC is important to developers of drugs and biologics that are intended for direct delivery to the CNS, as they are looking to use an FDA-cleared catheter for their IND-based clinical trials,” said Dr. Vogelbaum, Professor of Neurosurgery at Cleveland Clinic Lerner College of Medicine and Associate Director of Cleveland Clinic’s Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center.
The CMC features four independent delivery microcatheters. While the device was approved for delivery of a chemotherapy to the ventricles of the brain, its more general reliability as a loco-regional delivery device is being validated in IND-based pilot clinical trials involving delivery of a chemotherapy along with an MRI visible tracer in patients with recurrent high grade gliomas.
Since the first patient was treated in December 2014, 12 patients with malignant glioma have completed treatment with the device under the trial’s investigational protocol. For these procedures, two CMC devices have been placed in each patient using conventional neurosurgical stereotactic techniques. A chemotherapy has been infused along with an MRI visible tracer into tumor and/or tumor-infiltrated brain tissue via the microcatheters for up to 96 hours. Intermittent MRI monitoring has shown that the infusions have produced widespread distribution of the infusate into tumor-infiltrated brain.
“The extent of brain tissue covered and the reliability of the technique in these patients to date have surpassed past experience with other CED devices,” said Dr. Vogelbaum. As an inventor of the multiport catheter, Dr. Vogelbaum is entitled to a portion of any commercialization revenues Cleveland Clinic receives from Infuseon.
Additional investigations are continuing to determine optimal parameters for use of the CMC in solid tumors and in tumor-infiltrated brain. Use for treatment of other conditions affecting the brain and CNS, and in solid organs outside of the CNS, is also being explored.
Infuseon is currently seeking strategic partners with proprietary agents that can be delivered through their proprietary delivery devices. The company will be attending the 2017 BIO International Convention in San Diego, California, June 20-22.
About Infuseon Therapeutics
– Infuseon Therapeutics was founded in 2012 by Cleveland Clinic for the purpose of developing its unique therapeutic delivery devices. The patented Cleveland Multiport CatheterTM
(CMC) is the first to have entered human clinical trials. Infuseon has collaborated with Parker-Hannifin Corporation, a global leader in motion and control technologies to enhance the medical design, development, and manufacturing expertise of the company. To learn more visit www.infuseontherapeutics.com
Media contact: Neema Mayhugh, PhD firstname.lastname@example.org